The Rwanda Food and Drugs Authority (FDA) has warned of potential severe risks in patients with heart diseases who are treated with Clarithromycin - an antibiotic used to treat various infections including those affecting respiratory tract.

In a safety warning that was posted on its Twitter handle on Friday, January 15, 2021, the authority said that the warning stems from new safety information by World Health Organization (WHO).

Further reference, it said, was made to the drug safety communication published by the US Food and Drug Administration (US FDA) on the risks of cardiovascular events and death associated with the use of Clarithromycin.

On the risk of cardiovascular events associated with the use of the drug in question, FDA said they include prolongation of a condition in which the heart muscle takes longer than normal to recharge between beats, and arrhythmia during which the heart can beat too fast, too slowly, or with an irregular rhythm.

The authority also warned of myocardial infarction, commonly known as a heart attack, and death that can result from using this drug in patients with heart diseases.

It said that healthcare providers should be aware of significant risk and weigh the benefits of prescribing clarithromycin to patients with heart disease because of the increased risk of heart problems or death.

Prescribers, it added, should advise patients with heart disease of the signs and symptoms of cardiovascular problems.

"Patients with high-risk factors for heart disease should not be treated with Clarithromycin,” the medicine safety communication digitally signed by Charles Karangwa, Acting Director-General of Rwanda FDA, reads in part.

Moreover, the drug regulator requested the drug marketing authorisation holders to add boxed warning to the prescribing information for the risk of death and cardiac problems for patients with heart diseases under Clarithromycin treatment.